1. Field of the Invention
The present invention is directed to a pre-filled vial assembly adapted for dispensing and delivery of a fluid. More particularly, the present invention is directed to a pre-filled active vial having an integral plunger assembly for delivering a fluid that may be directly attached to a standard hypodermic syringe. A regulator for regulating the release of air from the pre-filled vial assembly is also disclosed.
2. Description of Related Art
Syringe assemblies, and in particular hypodermic syringes, are well known in the medical field for dispensing fluids, such as medication. A conventional syringe typically includes a syringe barrel with an opening at one end and a plunger mechanism disposed through the other end. The plunger typically includes a plunger rod extending through the barrel, with a plunger head or stopper at the end of the plunger rod within the barrel and with a finger flange at the other end of the plunger rod extending out of the barrel. In use, the plunger rod is retracted through the syringe barrel to fill the syringe barrel with a fluid, such as a medication, with the plunger rod extending out from the rear end of the syringe barrel. For delivery of the medication to a patient, the opening of the syringe barrel is adapted for fluid communication with a patient, such as through a hypodermic needle fitted at the front end of the syringe barrel or through a luer-type fitting extending from the front end of the syringe barrel for attachment with a fluid line of a patient. Upon depressing of the plunger rod, the plunger rod and stopper travel through the syringe barrel, thereby forcing the contents of the syringe out through the opening at the front end for delivery to the patient. Such an operation is well known in the medical field, and medical practitioners have become well accustomed to the use of such common fluid delivery procedures through standard syringes.
Conventional syringes are well known to be used in connection with a vial of a medication, where the user draws the fluid into the syringe immediately prior to injection and delivery of the fluid to the patient. Oftentimes, hypodermic syringes may be packaged as “pre-filled” devices, wherein the syringe is pre-filled with medication prior to being packaged and delivered to the end user. In this manner, there is no need for the user to fill the device prior to injection, thereby saving time for the end user and maintaining consistent volumes for delivery.
Pre-filled syringes and pre-filled metered dose syringes are often filled with narcotics or other drugs at a production facility, packaged, and then shipped to a medical facility. Once at the facility, these syringes are often placed in controlled storage and/or locked cabinets to reduce theft of the syringes themselves and/or theft of the contents of these syringes. The space within these controlled storage locations is often limited, thus there is a need for a syringe assembly that has a smaller packaging footprint, to reduce the storage space required for containing this syringe.
For some applications, small vials and ampoules are used to store medications and other narcotics or controlled substances. These vials and ampoules are typically storage vessels and do not typically include a plunger rod or stopper. During use, a medical practitioner draws the medication or controlled substance from the vial or ampoule by inserting the needle of a standard syringe therein and withdrawing the contents. The process of transferring the contents of a vial or ampoule into a syringe for injection increases the likelihood of contamination. In addition, as the majority of ampoules are glass, the transfer process increases the likelihood that shards of glass may become incorporated into the injected fluid.